Amis K Long femoral stems

GUDID 07630971265561

AMIS-K LONG Size 3S2 Length 250mm

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630971265561
• NIH Device Record Key: 98d48c03-9ba7-4c76-b54b-1e1ab726f2c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amis K Long femoral stems
• Version Model Number: 01.20.210
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630971265561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220405

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-29
• Device Publish Date: 2022-04-21

On-Brand Devices [Amis K Long femoral stems]

• 07630971265660: AMIS-K LONG Size 5R1 Length 300mm
• 07630971265653: AMIS-K LONG Size 5R1 Length 250mm
• 07630971265646: AMIS-K LONG Size 5R1 Length 200mm
• 07630971265639: AMIS-K LONG Size 4S2 Length 300mm
• 07630971265622: AMIS-K LONG Size 4S2 Length 250mm
• 07630971265615: AMIS-K LONG Size 4S2 Length 200mm
• 07630971265608: AMIS-K LONG Size 4S1 Length 300mm
• 07630971265592: AMIS-K LONG Size 4S1 Length 250mm
• 07630971265585: AMIS-K LONG Size 4S1 Length 200mm
• 07630971265578: AMIS-K LONG Size 3S2 Length 300mm
• 07630971265561: AMIS-K LONG Size 3S2 Length 250mm
• 07630971265554: AMIS-K LONG Size 3S2 Length 200mm
• 07630971265547: AMIS-K LONG Size 3S1 Length 300mm
• 07630971265530: AMIS-K LONG Size 3S1 Length 250mm
• 07630971265523: AMIS-K LONG Size 3S1 Length 200mm
• 07630971265516: AMIS-K LONG Size 2S2 Length 300mm
• 07630971265509: AMIS-K LONG Size 2S2 Length 250mm
• 07630971265493: AMIS-K LONG Size 2S2 Length 200mm
• 07630971265486: AMIS-K LONG Size 2S1 Length 300mm
• 07630971265479: AMIS-K LONG Size 2S1 Length 250mm
• 07630971265462: AMIS-K LONG Size 2S1 Length 200mm